Certara

Certara is happy to host the pre-roundtable dinner at the upcoming Linking Leaders Medical Writing event! Why is this important? Because the most valuable moments often happen outside the formal agenda. This dinner is a chance for experienced professionals to connect, share insights, and inspire each other in a relaxed setting. If you’re attending, we're looking forward to seeing you there. Together, we’ll create space for the meaningful conversations that drive progress. #MedicalWriting #RegulatoryWriting #Leadership #LinkingLeaders #Community Demetrius Carter Laura Sheppard

𝗖𝗼𝗺𝗽𝗹𝗲𝘅 𝗔𝗻𝘁𝗶𝗯𝗼𝗱𝘆-𝗱𝗿𝘂𝗴 𝗖𝗼𝗻𝗷𝘂𝗴𝗮𝘁𝗲 (𝗔𝗗𝗖) 𝗦𝘁𝗿𝘂𝗰𝘁𝘂𝗿𝗲 𝗗𝗼𝗲𝘀𝗻’𝘁 𝗡𝗲𝗲𝗱 𝗖𝗼𝗺𝗽𝗹𝗲𝘅 𝗠𝗼𝗱𝗲𝗹𝗶𝗻𝗴 ADCs are an emerging class of cancer therapies that combine a targeted antibody with a potent drug payload. While effective, their complex structure—linking antibody, drug, and linker—makes it difficult to predict how they behave in the body, leading to challenging pharmacokinetic (PK) assessments. In this webinar, Certara’s pharmacometrics consulting experts—Martin Beliveau, Vice President, and Eline van Maanen, Director—along with Senior Scientist, Kang Lin, from Avidity Biosciences, Inc. will share how to apply a simplified, fit-for-purpose approach to #ADC pharmacokinetic (PK) modeling. ·  Understand when Non-compartmental Analysis (NCA) is enough—and when to move to popPK ·  Learn how to handle Drug-to-Antibody Ratio (DAR) variability and analyte selection ·  Explore real-world models that support smart decision-making 🔗 Register here: https://xmrrwallet.com/cmx.plnkd.in/e5vAY6vZ #ADC #AntibodyDrugConjugate #Pharmacokinetics #PopPK #ModelingAndSimulation #OncologyResearch #DrugDevelopment #NCA #ADC

In this video, Piet van der Graaf explains why the next step in model-informed drug development is using this technology to support personalized medicine. Watch the full video here: https://xmrrwallet.com/cmx.plnkd.in/eBCuDn-k #DrugDevelopment #PharmaInnovation #MIDD

Regulatory submissions demand accuracy, traceability, and compliance with CDISC SDTM standards. Traditional, manual approaches can slow you down. But now there’s a better way... Discover how a collaborative, metadata-driven workspace brings efficiency and improved quality benefits to your SDTM mapping process. Listen to our on-demand webinar to learn more: ➡️ Watch the webinar here >> https://xmrrwallet.com/cmx.plnkd.in/ekEdU33h #SDTMmapping #CDISC #Certara #Pinnacle21

Join us in congratulating Amin Rostami-Hodjegan on receiving the 2025 Lewis B. Sheiner Lecturer Award! This distinguished award honors scientists who embody the Circle of Excellence: Integration – Innovation – Impact—a framework recognizing transformative contributions to research, drug development, and regulatory science. Throughout his career, Amin has exemplified these principles. His leadership has driven the global adoption of model-informed approaches, reshaping how therapies are developed, evaluated, and ultimately delivered to patients. The award is especially meaningful given Amin’s early inspiration from Dr. Lewis Sheiner, whose PK/PD course he attended early in his career—a formative experience that helped shape his scientific path. We look forward to celebrating this achievement together at ACoP 2025 this October in Colorado. Congratulations, Amin! #ISoP #ACoP2025 #Pharmacometrics

Can You Predict a Drug’s Impact on Heart Rhythm Without a TQT Study? Model-Based C‑QTc Analysis Shows You Can A drug’s potential to affect heart rhythm can be evaluated based on its effects on the QT interval—traditionally requiring a costly TQT study. However, early model-based exploratory analysis can now be used to make faster, informed decisions about the appropriate development pathway. At Certara, we’re challenging the assumption that every new drug needs a standalone, multi-million-dollar thorough QT/QTc (TQT) trial. Our latest blog explores how model-based C‑QTc analysis can: ✔️ Use ECG + PK data from early-phase studies ✔️ Predict QTc risk via exposure–response modeling ✔️ Support regulatory decisions and waive TQT studies The result? A smarter, faster, and more cost-effective path to cardiovascular safety. Read the full blog to see how exploratory modeling is reshaping cardiac safety strategies: https://xmrrwallet.com/cmx.plnkd.in/eNKM6fRE #CardiacSafety #QTc #CQTc #DrugDevelopment #ClinicalPharmacology #TQT #ModelBasedApproach

𝗛𝗼𝘄 𝗱𝗼 𝘄𝗲 𝗯𝗲𝘁𝘁𝗲𝗿 𝗰𝗼𝗻𝗻𝗲𝗰𝘁 𝗽𝗿𝗲𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝘄𝗶𝘁𝗵 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝘆? Hear how integrated 𝗠𝗜𝗗𝗗 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝘀 are strengthening early development, bridging the translational gap between nonclinical models and human trials. Join Certara + ASCPT for an expert-led session that explores real-world applications of model-informed drug development. 🔗 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗡𝗼𝘄 https://xmrrwallet.com/cmx.plnkd.in/dnzH3sRd #PreclinicalTranslation #MIDD #ASCPT #ClinicalPharmacology #DrugDevelopment

The European Medicines Agency (EMA) has officially qualified Certara’s Simcyp®️ Simulator (v19) for predicting CYP-mediated drug-drug interactions (DDIs) — making it the first and only PBPK platform to receive this recognition. - What does this mean for drug developers and regulators? - Why is this milestone important? - What was the qualification process like? In our latest blog, Karen Rowland Yeo, SVP of Client & Regulatory Strategy at Certara, breaks down the impact of this qualification and what it means for the future of PBPK in regulatory submissions. 📖 Read the blog: https://xmrrwallet.com/cmx.plnkd.in/e8nhXGT4 #PBPK #Simcyp #MIDD #DrugDevelopment #Pharmacokinetics #EMAQualification

Needle in the Haystack: The Role of Data Fabrics in AI AI can transform drug development—if the data foundation is right. Join Certara.AI experts to learn: ✅ Common data pitfalls ✅ How to prep your AI environment ✅ Which models work best 🔗 Register now: https://xmrrwallet.com/cmx.plnkd.in/eV7yQaSS #AIinPharma #DrugDevelopment #CertaraAI #LifeSciencesAI

𝗔𝗰𝗰𝗲𝗹𝗲𝗿𝗮𝘁𝗲 𝗣𝗞/𝗣𝗗 𝗦𝗰𝗶𝗲𝗻𝗰𝗲 𝘄𝗶𝘁𝗵 𝗔𝗜 & 𝗖𝗹𝗼𝘂𝗱 APAC Webinar | Aug 21, 2025 | 10am Japan/Korea Facing complex studies + resource constraints? Discover how Certara’s 𝗣𝗵𝗼𝗲𝗻𝗶𝘅—the industry gold standard—uses 𝗰𝗹𝗼𝘂𝗱 𝘄𝗼𝗿𝗸𝗳𝗹𝗼𝘄𝘀 & 𝗔𝗜 to: ✅ Automate TFLs & PK reports ✅ Enable secure cross-team collaboration ✅ Simplify data flagging/QTC analysis 𝗧𝗿𝗮𝗻𝘀𝗳𝗼𝗿𝗺 𝗱𝗮𝘁𝗮-𝘁𝗼-𝗶𝗻𝘀𝗶𝗴𝗵𝘁 𝗲𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝗰𝘆 while maintaining scientific control & compliance. Reserve your spot: https://xmrrwallet.com/cmx.plnkd.in/dbajC6Az #PKPD #DrugDevelopment #Phoenix #AI